NATRELLE Silicone-Filled Breast Implants 20-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888628001787), received between May 13, 2019 and Sep 24, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 reports).

4 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892384 ↗
• InjurySep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892372 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported through National Breast Implant Registry "Wrinkling/Rippling, Correction of Asymmetry". Patient underwent a capsulectomy/ capsulotomy. This record is for the left side. The device was explanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling

  MAUDE report 50760901 ↗
• InjuryJun 11, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A NO COMPLAINT AGAINST THE DEVICE. LATER REPORTED A RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471010 ↗
• InjuryFeb 25, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24440128 ↗
• InjuryDec 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE 4", "FIRM, PAINFUL, AND RAISED ON THE CHEST.", "LYMPH NODE", "DEFORMITY OF THE RECONSTRUCTED BREAST" "CALCIFICATION", "ITCHING", "RASH" AND "SWELLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23811601 ↗
• InjuryDec 12, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE", "DISCOMFORT", "DEFORMITY OF THE RECONSTRUCTED BREAST", "CALCIFICATION", "ITCHING", "RASH" AND "SWELLING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23796675 ↗
• InjuryDec 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE SEEN DURING EXPLANT SURGERY". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND IT'S UNKNOWN IF THE DEVICE WAS REPLACED. UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23743919 ↗
• InjuryDec 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23743374 ↗
• InjuryNov 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE" WITH NO TREATMENT. HEALTHCARE PROFESSIONAL REPORTED "LOW RIDING IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23532512 ↗
• InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE" WITH NO TREATMENT. HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23498793 ↗
• InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23434020 ↗
• InjuryOct 27, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23391921 ↗
• InjuryOct 16, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE". LATER PATIENT REPORTED "ACTUALLY EXPLODED AND TOOK SURGEON'S OFFICE UP TO 8 HOURS TO REMOVE SILICONE FROM BODY". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23308785 ↗
• InjuryOct 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "INTACT, BAKER GRADE 4". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23267220 ↗
• InjuryOct 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" CONFIRMED VIA PHYSICAL EXAMINATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23248939 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CONTRACTURE¿. LATER REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22996438 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CONTRACTURE¿. HEALTHCARE PROFESSIONAL LATER REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22994648 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22938103 ↗
• InjuryAug 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22787711 ↗
• InjuryNov 8, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED, LEFT SIDE RUPTURE, PAIN. AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18097744 ↗
• InjuryJan 5, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16102726 ↗
• InjuryNov 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15741133 ↗
• InjuryApr 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE CAPSULAR CONTRACTURE (BAKER GRADE III)". DEVICE EXPLANTED. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 14207090 ↗
• InjuryMar 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11451275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
• Z-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR